You lead a team focused on regional regulatory activities in the EUCAN region, ensuring compliance and effective strategy execution while fostering team development and project leadership.
Anforderungen
- •Doctoral or Master's Degree in pharmacy
- •Long-term experience in Regulatory Affairs
- •Several years of experience in Oncology projects
- •In-depth knowledge of EUCAN regulatory requirements
- •Experience with Health Authority interactions
- •Proven leadership of cross-functional teams
- •Ability to work collaboratively cross-functionally
- •Fluent English skills, both written and spoken
Deine Aufgaben
- •Lead and manage a team of Regional Regulatory Leads.
- •Steer and coordinate regional regulatory activities for EUCAN.
- •Ensure delivery of robust regional regulatory strategies.
- •Monitor and enhance team members' functional development.
- •Support the Head of RA in establishing objectives and strategies.
- •Lead assigned development and general projects.
- •Contribute to common standards and procedures within the group.
Original Beschreibung
# Head of Team Regional Regulatory Leads
## The Position
You will lead and manage a team of Regional Regulatory Leads (RRL) for EUCAN Region.
## Tasks & responsibilities
* In your new role, you will lead and manage a Team of Regional Regulatory Leads responsible for steering and coordination of regional regulatory activities for the EUCAN region required for development, maintenance, and expansion of world-wide marketing authorizations for the assigned BI’s global human pharma portfolio.
* With your expertise, you will ensure the delivery and execution of robust regional regulatory strategies for the EUCAN region, while ensuring our regulatory compliance.
* You will monitor and enhance the functional and personal development of the team members to drive the team goals.
* Furthermore, you will provide support to the Head of RA in establishing objectives, strategies, and priorities for the complete EUCAN team under consideration of the overall objectives.
* You will also lead assigned development projects as well as general projects, while additionally contributing to our common standards and procedures within the group.
## Requirements
* Doctoral Degree (e.g. PhD, MD) and/or Master’s Degree in pharmacy or life sciences. Further degrees, e.g., Specialized Pharmacist or Master of Drug Regulatory Affairs are appreciated
* Long-term experience in the pharmaceutical industry in Regulatory Affairs, and ideally also in functions outside Regulatory Affairs (e.g. research and development)
* Several years of practical experience in development projects in Oncology in the EUCAN region, with a special focus on the EU regulatory strategy
* In depth knowledge of international regulatory requirements including the understanding, interpretation, and application of regulatory legislation in the EUCAN region, with focus on EMA (European Medicines Agency)
* Experience with direct Health Authority interactions (e.g. EMA/BfArM) and in handling new developments, registrations and maintenance of products
* Proven experience in successful leadership of international and cross functional project teams
* Ability to collaboratively work cross-functionally in- and outside of the regulatory affairs organization with a good understanding of different cultures and their impact
* Fluent English skills, both written and spoken